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Enhancing the Effectiveness of Home-delivery Based Produce Prescription Program Implementation Strategies

Enhancing the Effectiveness of Home-delivery Based Produce Prescription Program Implementation Strategies

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06114199
Enrollment
200
Registered
2023-11-02
Start date
2024-07-26
Completion date
2025-11-25
Last updated
2025-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Deficiency in Pregnancy

Brief summary

Harris Health System is currently participating, along with two other partners, GoldiFresh Inc., and Brighter Bites, in a cross-sector collaborative home delivery-based Produce Prescription Program (PPRx) pilot initiative that provides consistent access to healthy food plus nutrition education to Medicaid-eligible pregnant women in Harris County, TX, deemed to be at high risk of adverse pregnancy or birth outcomes. The objectives of this study are two-fold: (a) to examine utilization of food basket contents and improvements in diet quality in this home delivery based PPRx program, and (b) to evaluate if and the extent to which utilization of food basket contents outcomes improves with support from an interactive AI-based conversational agent to convert food into healthy meals.

Interventions

BEHAVIORALProduce Prescription Program (PPRx) Standard

Participants will receive biweekly deliveries of 20 lbs (\ 50 servings) of fresh produce (8-10 different kinds of produce) plus standard nutrition education materials consisting of nutrition education infographics inside of the produce prescription boxes as well as online videos, recipes, and nutrition tips accessed via Quick Response (QR) code.

BEHAVIORALSmartphone App

Participants will be given access to a smartphone app that allows women to interact with an artificial intelligence (AI) chatbot to obtain real-time cooking suggestions.

Sponsors

American Heart Association
CollaboratorOTHER
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

Inclusion criteria

* receiving prenatal care at high-risk obstetric clinics * \<= 20 weeks medically-confirmed viable pregnancy * designated as high risk \[Age\>=35 years, or obese or overweight (BMI\>=25.0 at pre pregnancy self-report), or prior history of pregnancy hypertension or gestational diabetes\] * within the zip code delivery radius

Exclusion criteria

* women who were medically recommended bed rest through pregnancy * substance users

Design outcomes

Primary

MeasureTime frameDescription
Change in consumption of home-delivered produce from baseline to 6 monthsMeasures will be collected at baseline, and 6 times at random intervals over the next 6 months7 point rating scale ranging from 0=none to 6=all, assessing what proportion of delivered produce was consumed over the past two weeks.
Change in usual consumption of fruits and vegetables from baseline to 6 monthsMeasures will be collected at baseline, and after 6 months of exposure to programFruit and vegetable consumption scale, measured by NCI dietary screener. Scale includes multiple sources of fruit and vegetables in diet, and is scored in terms of cups of fruit / day, and cups of vegetables / day

Countries

United States

Contacts

Primary ContactNalini Ranjit, PhD
Nalini.Ranjit@uth.tmc.edu(512) 391-2527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026